Catalog Number 320-46-03 |
Device Problems
Loose or Intermittent Connection (1371); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Joint Disorder (2373); No Information (3190)
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Event Date 01/30/2018 |
Event Type
Injury
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Manufacturer Narrative
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Pending evaluation.
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Event Description
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Revision of shoulder components due to loosening.
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Manufacturer Narrative
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Pending evaluation.Updated with device information and index surgery date.Mdr is associated with 1038671-2018-00270.
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Event Description
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Revision of shoulder components due to loosening.
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Event Description
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The revision surgery was related to a post traumatic event, the patient was lifting a 50 lb bag of mulch.Associated mfrs for this event: 1038671-2018-00270.
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Manufacturer Narrative
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It is noted in the ifu that a patient's age, weight, or activity level would cause the surgeon to expect early failure of the system.There is no indication that there is a device related problem/malfunction.The most likely cause of the reported event is related to patient weight and strenuous activity.Correction, no device evaluation to be performed.This device is used for treatment, not diagnosis.
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Search Alerts/Recalls
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